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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameADEZA FETAL FIBRONECTIN EIK
Classification Nameenzyme immunoassay, fetal fibronectin
ApplicantADEZA BIOMEDICAL
PMA NumberP920048
Supplement NumberS001
Date Received06/26/1996
Decision Date01/08/1997
Product Code
LKV[ Registered Establishments with LKV ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification of the intended use statement as follows: "the device is further indicated for use in conjunction with other clinical info as an aid in assessing the risk of preterm delivery in < 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton gestation. The positive predictive value ranges from 13. 3% to 31. 7% for delivery in < 34 weeks, 6 days and represents an approximate 4- to 7-fold increase in risk over the reliability of predicting delivery given no test info. The negative predictive value ranges from 96. 4% to 97. 9% making it highly likely that delivery will not occur in these time frames. ".
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